Ignite Creation Date:
2024-05-06 @ 1:58 AM
Last Modification Date:
2024-10-26 @ 11:12 AM
Study NCT ID:
NCT01943474
Status:
COMPLETED
Last Update Posted:
2017-03-09
First Post:
2013-04-08
Brief Title:
AccuCath Guidewire Intravenous IV Device Versus Conventional IV Catheter In General Nursing Use
Sponsor:
C R Bard
Organization:
C R Bard
Study Overview
Official Title:
The AccuCath Intravenous Catheter System With Retractable Coiled Tip Guidewire and Conventional Peripheral Intravenous Catheters A Prospective Randomized Controlled Comparison by General Hospital Nursing Staff
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study will test a hypothesis that the AccuCath System will have a higher rate of successful first attempt peripheral intravenous IV placement higher completion of therapy fewer complications longer dwell times and higher user satisfaction compared to conventional IV catheters
Detailed Description:
This study is designed to evaluate userphysician preference as it relates to use of a 510k cleared vascular access and catheter device compared with conventional needlecatheter vascular access devices in terms of first stick success rates dwell time device-related vascular complications and adverse events and overall user and patient satisfaction As noted above the study is designed to formally test the hypothesis that the AccuCath System will exhibit superiority in terms of the rate of successful first attempt peripheral IV placement higher completion of therapy fewer complications longer dwell times and higher user satisfaction compared to conventional intravenous catheters
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None